drugset
drugset / Trial / NCT06997367

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)

NCT06997367 ↗

Phase 2 Active not recruiting 164 enrolled Bharat Biotech International Limited
RandomizedParallel-groupTriple-blindPrevention

Summary

Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and adolescents.

Timeline

Start
2025-03-27
Primary completion
2025-09-01
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MTBVAC Vaccine 0.1 ml Intravenous
Comparator TUBERVAC- Moscow strain Vaccine 0.1 ml Intravenous

Indications

tuberculosis